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China’s first trispecific antibody CC312 freeze-dried powder injection based on CD28 costimulatory signal has been approved for clinical trials by NMPA

On March 10, 2023 Huihe Biotechnology (CytoCares) reported that its CC312 was approved for clinical trial license by the NMPA (Acceptance number: CXSL2200621), the indication is relapsed/refractory CD19-positive B-cell malignant hematological tumors (Press release, CytoCares, MAR 10, 2023, View Source [SID1234635271]). CC312 is TriTE independently developed by Huihe Biotech. The first product of the platform is also the first trispecific antibody based on CD28 costimulatory signal to be clinically approved in China and the third in the world. This is another milestone after CC312 obtained FDA clinical implicit approval on May 14, 2022, marking the product entering the clinical research stage in China and the United States.

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CC312 is Huihe Biotechnology’s first TriTE-basedTM(Tri-specific T-cell Engager) technology platform independently developed project with independent intellectual property rights. Full activation of T cells requires the synergistic effect of two stimulatory signals, including the first stimulatory signal acting on the CD3/TCR complex, and the costimulatory signal acting on receptors such as CD28 or 4-1BB. Among them, the loss of any signal may lead to incomplete activation of T cells or incompetence or apoptosis after activation. TriTETMThe platform is based on the "dual signal" activation mechanism of T cells and uses co-stimulation signals as the "amplifier" of the first stimulation signal to achieve sustained and sufficient activation of T cells.

CC312 is composed of three single-chain variable region fragments (scFv) targeting CD19, CD3 and CD28 antigens . The three functional domains are connected by a flexible fragment and an IgD hinge region fragment. The T T receptor mediated by the antibody molecule of this structure The immune synapse formed between cells and target cells is closest to the immune synapse mediated by TCR and MHC complexes under natural conditions. By targeting the CD19 functional domain, T cells are precisely directed to tumor cells, and then T cells are fully activated through CD3xCD28 dual stimulation activation signals. Activating T cells with a "dual signal" regulatory mechanism has a longer-lasting activation effect on effector cells and can induce T cells to differentiate into memory T cells. CC312 also has strong tumor suppressive activity at low dosing frequency, thereby Can improve clinical dosing patterns.

Amgen’s blinatumomab (trade name Blincyto) targets CD3xCD19, which is not only expensive, but also requires continuous intravenous infusion for 4 weeks. The administration mode is very inconvenient. CC312 (CD19xCD3xCD28) has shown good pharmacological properties, bioavailability, and safety in preclinical studies for hematomas. As well as effectiveness and longer half-life , it is an upgraded version of the CD19xCD3 dual antibody and has clinical substitution. As an antibody-based version of CAR-T, CC312 has unique advantages in terms of patient compliance and accessibility. It combines the advantages of CAR-T, monoclonal antibodies, and dual antibodies, and has great potential to replace CAR-T therapy.

Dr. Zhu Huaxing, founder and chairman of Huihe Biotechnology, said "The CC312 project has obtained clinical trial research approval from NMPA, which is a major milestone for Huihe Biologics. As China’s first triple-antibody drug based on a dual-signal activation mechanism to obtain IND approval from China and the United States, it has broken the boundaries of foreign new drug development. We are very proud of our monopoly position. We will fully promote the phase I clinical research of CC312 and benefit more subjects as soon as possible. Huihe will also continue to uphold the principle of "continuous innovation, benefiting the people, working together with one heart, and embracing all rivers." The concept of providing more, better and more affordable new drugs for clinical practice and patients."

Abcam to Report Full Year Results on Monday, March 20, 2023

On March 10, 2023 Abcam plc (Nasdaq: ABCM) ("Abcam" or the "Company"), a global leader in the supply of life science research tools, reported its results for the year ended 31 December 2022 at 7.00 a.m. ET on 20 March 2023 (Press release, Abcam, MAR 10, 2023, View Source [SID1234628563]).

Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. ET that same day (details below).

To access the webcast, please use the following link:

View Source

The press release and the live audio webcast will also be available in the investor section of Abcam’s corporate website at corporate.abcam.com/investors/reports-presentations/. An archive will be available after the call at that same address.

For further information please contact:

Abcam
Tommy Thomas, CPA, Vice President, Investor Relations
+1 617 577 4205

Aptose Reports Immaterial Financial Exposure to Silicon Valley Bank

On March 10, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (Nasdaq: APTO; TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported related to Silicon Valley Bank ("SVB") and questions raised by interested parties (Press release, Aptose Biosciences, MAR 10, 2023, View Source [SID1234628547]).

Aptose has not entered into a line of credit with SVB, and therefore has no exposure related to any credit facility.

Aptose held a deposit account at SVB with approximately $0.3 million in excess of the $250,000 FDIC-insured limit. Aptose does not believe these amounts represent a material portion of its cash and cash equivalents. The Company does not expect any material impact on operations, payroll, or ongoing clinical trials.

Non-SVB institutions serve as custodians for investments held in Aptose’s name, and we envision no direct exposure to those investments as a consequence of a liquidity concern at SVB.

Miravo Healthcare™ Obtains Final Order Approving Plan of Arrangement

On March 10, 2023 Nuvo Pharmaceuticals Inc. d/b/a Miravo Healthcare (TSX:MRV; OTCQX:MRVFF) ("Miravo" or the "Company") reported that it has obtained a final court order from the Ontario Superior Court of Justice (Commercial List) approving its previously announced arrangement (the "Arrangement") with Searchlight Pharma Inc. (the "Purchaser") (Press release, Nuvo Pharmaceuticals, MAR 10, 2023, View Source [SID1234628545]).

The Arrangement is expected to close on or about Tuesday, March 14, 2023, subject to the satisfaction or waiver of all conditions to the Arrangement. Following completion of the Arrangement, the Company will be de-listed from the TSX and applications will be made for the Company to cease to be a reporting issuer in each of the provinces of Canada. Pursuant to the terms of the Arrangement, each holder of common shares in the capital of the Company (the "Company Shares") will receive $1.35 in cash, less applicable withholdings.

To receive the consideration under the Arrangement, each registered shareholder of the Company must complete, sign, date and return the letter of transmittal, which accompanied the Company’s management information circular dated February 6, 2023.

The consideration to be paid to the Company’s shareholders under the Arrangement is denominated in Canadian dollars. However, registered shareholders of the Company may elect to receive the consideration in U.S. dollars in the applicable letter of transmittal. Non-registered shareholders of the Company must contact the intermediary in whose name their Company Shares are registered in order to make such an election on their behalf.

CRINETICS PHARMACEUTICALS ANNOUNCES INDUCEMENT GRANTS UNDER NASDAQ LISTING RULE 5635(C)(4)

On March 10, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that on March 10, 2023, the Compensation Committee of Crinetics’ Board of Directors granted non-qualified stock option awards to purchase an aggregate of 250,300 shares of its common stock to eight new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") (Press release, Crinetics Pharmaceuticals, MAR 10, 2023, View Source [SID1234628540]). The stock options were granted as inducements material to the employees entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

The 2021 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Crinetics, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Crinetics, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $17.28 per share, which is equal to the closing price of Crinetics’ common stock on The Nasdaq Global Select Market on March 10, 2023. The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The options are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the grant.